About this trial
Background:
Multiple adaptations at the cardiovascular system occurs during pregnancy. In the pregnancy condition pre-eclampsia (PE), this adaptations are abnormal. Five to eight percent of all pregnant women worldwide will develop PE.
PE is a pregnancy condition which is characterized with a high blood pressure (\>140/90 mm Hg) and the occurrence of proteinuria (\>3g/dl/24h) after 20 weeks of gestation. When untreated, this condition can have severe complications for both mother and child. It's important to monitor women with a high risk for developing PE for an early detection and treatment of this condition.
For this reason, a multicenter study is set up with the following applications:
1. NICCOMO and Maternal Venous Doppler Echography: impedance cardiograph and an echography of the heart and veins. 2. Maltron: bio-electronic impedance analyze 3. Remote monitoring of the high risk patients to become a more intensive follow-up
Number of inclusions: 2000 pregnant women from the prenatal consultations of eight different hospitals:
Eligibility criteria
Qualifiers
> 10 weeks of pregnancy, primipara and multipara
Disqualifiers
< 10 weeks of pregnancy and congenital malformations of the fetus
Trial design
Treatments tested in this trial
- remote monitoring
Treatment groups
Sponsors and collaborators
Hasselt University
Lead sponsor
Ziekenhuis Oost-Limburg
Collaborator